Validation of the 3D-CAM Turkish Version
Primary Purpose
Delirium, Validity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
3d cam
DSM 5
Sponsored by
About this trial
This is an interventional other trial for Delirium
Eligibility Criteria
Inclusion Criteria:
- 18 years and older
- ASA Physical Status 1-3
- Admitted to the ICU after surgery with a predicted length of stay for more than 48 h
- MMSE ≥ 20 (to exclude dementia)
Exclusion Criteria:
- Refused to participate
- Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication
- Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism
- Deep sedation or coma
- ASA physical status IV or V
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Delirium
Arm Description
Outcomes
Primary Outcome Measures
Assessment of delirium
Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.
Secondary Outcome Measures
Full Information
NCT ID
NCT04853706
First Posted
April 13, 2021
Last Updated
April 20, 2021
Sponsor
Aydin Adnan Menderes University
1. Study Identification
Unique Protocol Identification Number
NCT04853706
Brief Title
Validation of the 3D-CAM Turkish Version
Official Title
Validation of the 3D-CAM Turkish Version in Surgical ICU Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 18, 2021 (Anticipated)
Primary Completion Date
October 18, 2021 (Anticipated)
Study Completion Date
December 18, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
3D CAM into Turkish validity and reliability on postoperative delirium will be test as a prospective diagnostic study. After approval by Dr. Edward R. Marcantonio, (15) will translation and back-translation. The original 3D-CAM will translate into Turkish by two medical doctor .The two translational versions will be discussed and merged into a final version. Back translation will performed in regardless of any information from its original version by another two medical doctor. Both the translated and back translated versions will sent to Dr. Marcantonio for approval. Eligibility and the documentation of consent will be confirmed at the preoperative visit. During this visit, patients will provide demographic and historical medical information, including information regarding medication usage. The Mini-Mental State Exam (MMSE) will be performed.
Delirium assessment
Delirium assessment with the 3D-CAM Before the study period, all researchers will participate online training program on 3D CAM. Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days.
Delirium assessment with the DSM-5 The psychiatrist investigator who was blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Validity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
245 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Delirium
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
3d cam
Intervention Description
The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm
Intervention Type
Diagnostic Test
Intervention Name(s)
DSM 5
Intervention Description
The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.
Primary Outcome Measure Information:
Title
Assessment of delirium
Description
Delirium will be evaluated using the 3D CAM every each morning and evening (18:00-20:00) for postoperative 3 days. The psychiatrist investigator who will be blinded to the 3D-CAM assessment results, will evaluate the patients according to the criteria of DSM-5 within 3 min after the 3D-CAM assessment.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years and older
ASA Physical Status 1-3
Admitted to the ICU after surgery with a predicted length of stay for more than 48 h
MMSE ≥ 20 (to exclude dementia)
Exclusion Criteria:
Refused to participate
Patients with severe visual or auditory disorder/handicaps or endotracheal intubation which might impede communication
Presence of a major psychiatric condition such as bipolar disorder, major depression, schizophrenia, Alzheimer or dementia, Parkinsonism
Deep sedation or coma
ASA physical status IV or V
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SINEM S OZTURK
Phone
4441256
Email
sarisinem@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32204700
Citation
Mu DL, Ding PP, Zhou SZ, Liu MJ, Sun XY, Li XY, Wang DX. Cross-cultural adaptation and validation of the 3D-CAM Chinese version in surgical ICU patients. BMC Psychiatry. 2020 Mar 24;20(1):133. doi: 10.1186/s12888-020-02544-w.
Results Reference
background
Learn more about this trial
Validation of the 3D-CAM Turkish Version
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